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The MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere radiation treatment is indicated.

The MRIdian Linac system (K162393; K170751) delivers ionizing radiation using a magnetic resonance imaging system (MRIS) unit for image guidance. This submission describes an optional change only to the treatment planning and delivery imaging workflows of the predicate MRIdian Linac system. ViewRay developed the following additional imaging modalities for use during MRIdian Linac system treatment planning and delivery workflows: 1. Introduction of a Treatment Delivery Computer Unit (TDCU) to increase treatment imaging reconstruction and display speed in excess of eight frames per second along with improved cine image resolution used for target tracking. 2. The predicate MRIdian Linac system supports the import of MR images obtained from a separate imaging system for use in treatment planning. In addition to importing additional MR images, the proposed MRIdian Linac system is also able to generate the following additional MR sequences for use during planning, positioning, and treatment delivery workflows: a. Turbo Spin Echo (TSE) pulse sequence family including Half Fourier Acquisition Single Shot Turbo Spin Echo (HASTE) and Diffusion Prepared Turbo Spin Echo (DP-TSE) which enables the following contrast protocols: i. T1-weighted (spin-lattice; magnetization in the same direction as the static magnetic field); ii. T2-weighted (spin-spin; magnetization transverse to the static magnetic field); and iii. Diffusion-Weighted Imaging (DWI) with ability to generate Apparent Diffusion Coefficient (ADC) maps to overlay and register to other images. b. True Fast Imaging (TRUFI) pulse sequence with radial sampling enabling higher speed imaging during treatment delivery. The currently marketed MRIdian Linac system integrates radiation therapy with simultaneous magnetic resonance imaging of soft tissues to provide optimal alignment, adaptation, and tracking. These proposed changes to the existing system described in this section aim to improve MR imaging speed and quality and provide additional image contrast modalities.

The provided text describes modifications to an existing MRIdian Linac System (K162393; K170751) and seeks to demonstrate substantial equivalence to the predicate device. However, it does not contain explicit acceptance criteria or a detailed study proving the device meets those criteria in the typical sense of a clinical performance study with human readers and ground truth for diagnostic accuracy.

Instead, the document focuses on technical equivalence and verification testing to ensure the new imaging modalities and hardware/software changes do not negatively impact the system's performance and meet safety and quality standards, making it substantially equivalent to the cleared predicate device.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

The document provides a "Predicate Device Comparison Chart" (Table 6-1 on page 8) which compares various technical attributes of the cleared device with the device with changes. While these are not framed as "acceptance criteria" in the sense of a clinical performance study (e.g., sensitivity, specificity), they represent the technical performance metrics that were likely considered in verifying equivalence.

2. POSITION
3. TREAT | Same | Maintain existing imaging settings and functionality. | Same |
   | MR Physical Characteristics: Bore Diameter | 700 mm | Same | Maintain physical dimensions. | Same |
   | Spherical Volume (DSV) | 500 mm | (Not specified for "Device with Changes," implied "Same") | Maintain diagnostic spherical volume. | (Implied 500 mm) |
   | MRI Frequency | 14.7 MHz | (Not specified for "Device with Changes," implied "Same") | Maintain MRI frequency. | (Implied 14.7 MHz) |
   | Field Strength | 0.345 T | (Not specified for "Device with Changes," implied "Same") | Maintain field strength. | (Implied 0.345 T) |
   | Field of View | 500 mm | Same | Maintain field of view. | Same |
   | Field Homogeneity |

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MOSAIQ® is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy are prescribed.

Users can configure MOSAIQ® for Medical Oncology use, Radiation Oncology use, or the two together. It lets users:

• · Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications.
• · Generate and keep medication formulary lists and calculate applicable medication dosages for medical oncology.
• · Import, view, annotate, adjust, enhance, manage and archive images.
• · Compare radiation treatment plans and evaluate dose coverage.
• · Design leaf plans for operation with radiotherapy treatment machines that have multileaf collimators.
• · Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints. MOSAIQ® reads actual settings from the treatment machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system warns the user.
• · View reference images to setup treatment. MOSAIQ® refers to predefined settings to help treatment machine setup, and communicates patient and machine setup instructions.
• · Record actual delivered radiation values in an electronic chart to track treatment.
• · Use stereotactic localization to calculate set-up coordinates for treatments.
• · Observation of Intrafractional motion with real time image overlay.

MOSAIQ® is not intended for use in diagnosis. Medical oncology dose calculation functions are designed for use with patients 18 years or older only.

The MOSAIQ Oncology Information System (OIS) is an image-enabled electronic medical record system. It manages clinical and administrative workflows within oncology departments and facilities efficient patient care. It can be configured for Medical Oncology, or both.

The Medical Oncology (MO) configuration is a medical oncology charting solution that includes customizable regimens (Care Plans) that automate chemotherapy orders for labs, procedures, and appointment views are used for reviewing treatment administration, documents, assessment and lab data. Users can enter medications and druglallergy interactions. MOSAIQ also performs standard calculations such as Body Sufface Area Under the Curve (AUC). The Medical Administration Record (MAR) supports all information related to chemotherapy and blood product administration, clinical trial study drugs, dose amounts, infusion time, multiple sites of administration, etc. MOSAQ's Medical Oncology functions are . It is labeled accordingly and calculates all doses accordingly.

The Radiation Oncology configuration is also a charting solution with computerized physician order entry (CPOE) capability, along with added features for image management, patient setup and record, plan import, review, and approval, stereotactic localization, and pretreatment checks. MOSAQ's Radiation Can be used to support a wide variety of treatment modalities including INRT. IGRT, particle therapy, and stereotactic radiotherapy. It can import and store treatment plans from TPS systems via DICOM import DICOM RT import.

The provided document, a 510(k) Premarket Notification for the Elekta MOSAIQ Oncology Information System, states that clinical trials were not performed as part of this product's submission. Instead, it indicates that "Validation testing involved simulated clinical workflows" and that "Non-clinical testing was written and executed to ensure that the system is working as designed."

Therefore, based on the provided text, the device did not undergo a study involving human subjects or a multi-reader multi-case (MRMC) comparative effectiveness study to prove it meets specific acceptance criteria related to its performance in a clinical setting with human readers. The document explicitly states:

• No clinical trials: "Clinical trials were not performed as part of this product. Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effective can be performed such that no human subjects are exposed to risk." (Page 6)
• Validation through simulated workflows and non-clinical testing: "Validation testing involved simulated clinical workflows, described in section 16.8. The product was deemed fit for clinical use. Non-clinical testing was written and executed to ensure that the system is working as designed use executed, including tests to verify requirements for new product functionality, tests to ensure that instion as intended, and regression tests to ensure continued safety and existing functionality. MOSAIQ passed testing and was deemed safe and effective for its intended use." (Page 6)

Given this, it's not possible to provide the requested information regarding:

• Acceptance Criteria Table and Reported Device Performance (Table 1): The document does not describe specific quantitative acceptance criteria or clinical performance metrics for the device that would be typically found in a clinical study report (e.g., sensitivity, specificity, accuracy). Its validation focused on functional correctness against design specifications.
• Sample size and data provenance for test set: No test set of clinical cases is described.
• Number of experts and qualifications for ground truth: No experts were used for establishing clinical ground truth for a test set.
• Adjudication method for test set: Not applicable as there was no clinical test set.
• MRMC comparative effectiveness study: Explicitly stated as not performed.
• Standalone performance: While internal non-clinical testing was done, the document doesn't provide performance metrics in the way an AI algorithm's standalone performance might be reported (e.g., AUC, F1 score).
• Type of ground truth: The "ground truth" for the non-clinical and simulated workflow testing would be the predefined system requirements and expected outputs, rather than expert consensus, pathology, or outcomes data from real patients.
• Sample size for training set: No training set for an AI/ML model is mentioned, as the device is described as an "Oncology Information System" and not an AI-driven diagnostic or assistive tool in the context of this submission.
• How ground truth for training set was established: Not applicable.

Summary of Device Validation as per the Document:

The provided document indicates that the device's safety and effectiveness were demonstrated through:

• Substantial Equivalence: Comparison to legally marketed predicate devices (MOSAIQ K141572) and a reference device (The ViewRay (MRIdian) Linac System K162393) based on intended use and technological characteristics (detailed in tables on Pages 8-9).
• Non-Clinical Testing: Verification tests to ensure the system works as designed, including:
  • Verification of new product functionality requirements.
  • Ensuring installation as intended.
  • Regression tests for continued safety and existing functionality.
• Simulated Clinical Workflows: Validation testing performed using simulated clinical scenarios, without human subjects.

This approach is common for information systems and record-keeping devices where the primary function is workflow management, data integration, and safety checks, rather than direct diagnostic interpretation or image analysis using AI. The "level of concern" for the software was identified as "major" due to its interface with linear accelerators and responsibility for detecting mismatches, which could lead to serious injury if it failed. Therefore, the non-clinical and simulated testing would have rigorously focused on these critical safety functions.

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